What device and App vendors need to understand about HIPAA Privacy and Security in a world of cell phone apps and peripherals, and other new stand-alone devices, that collect, transmit, and store Patient Identified Medical Data

The unregulated roles that smartphone apps are playing in violating the Privacy and Security requirements under HIPAA and the potential for liabilities

Examples of potential HIPAA Violations in both apps and devices

Design requirements for smartphone applications and standalone medical diagnostic devices in a connected world

How to approach a HIPAA compliance view, approaches to HIPAA compliance audits, and best practices for App and Device Manufacturers

A Consumer Driven Model for HIPAA Compliance in connected applications and devices

Check List For App & Device Compliance

Who Will Benefit:

Smartphone App Developers

Connected Device Developers

Business People using these devices or deploying them in their businesses

Health Care Regulators

Health Care Attorneys

Educational Objectives(S)

Upon completion of this activity, participants will be able to:

Explain how the use of devices and applications that are collecting or transmitting identified health care information may not be in compliance with Federal Statutes.

CME Credit Statement

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of CFMC and MentorHealth. CFMC is accredited by the ACCME to provide continuing medical education for physicians.

CFMC designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Other Healthcare Professionals Credit Statement

This educational activity has been planned and implemented following the administrative and educational design criteria required for certification of health care professions continuing education credits. Registrants attending this activity may submit their certificate along with a copy of the course content to their professional organizations or state licensing agencies for recognition for 1 hour.

Disclosure Statement

It is the policy of CFMC and MentorHealth that the faculty discloses real or apparent conflicts of interest relating to the topics of the educational activity. All members of the faculty and planning team have nothing to disclose nor do they have any vested interests or affiliations

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Obtaining Certificate of Credit

Colorado Foundation for Medical Care (CFMC) hosts an online activity evaluation system, certificate and outcomes measurement process. Following the activity, you must link to CFMC's online site (link below) to complete the evaluation form in order to receive your certificate of credit. Once the evaluation form is complete and submitted, you will be automatically sent a copy of your certificate via email. Please note, participants must attend the entire activity to receive all types of credit. Continuing Education evaluation and request for certificates will be accepted up to 60 days post activity date. CFMC will keep a record of attendance on file for 6 years.

Dr. McGuinness is a seasoned professional in regulatory compliance, with significant experience in both public and private sector compliance for Privacy, Security/Safeguards, Application (and Systems), and Business Process compliance. He has extensive 12 years’ experience in HIPAA regulation and compliance implementation, Co-founding Chairman of the HIPAA Conformance Certification Organization, certifications in HIPAA Privacy and Security, certified Chief Privacy Officer under HIPAA. He also has direct experience with GLBA, HIPAA, SOX (Sarbanes-Oxley), DoD DITSCAP, FDA Good Clinical Practice, FDA Electronic Records & Electronic Signatures (21CFR11), COPPA, FERPA, and is fluent in other many other regulatory environments.

Recently, he has been heavily involved in developing and refining compliance requirements for the non-traditional segments of the GLBA and HIPAA compliance communities, as well as SOX compliance. He is also extensive expertise in Dept. of Defense DITSCAP security regulatory requirements and certification, for both site and commercial products certifications. Of particular focus are regulatory harmonization compliance projects involving multiple overlapping regulatory schemas, such as: SOX + GLBA, HIPAA + GLBA, FERPA + HIPAA, FDA + HIPAA, etc.

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